Developing your research protocol

Every research project must have a protocol. The National
Research Ethics Service defines a protocol as:

"an essential part of a research project. It is a full
description of the research study and will act as a 'manual' for
members of the research team to ensure adherence to the methods
outlined. As the study gets underway, it can then be used to
monitor the study's progress and evaluate its
outcomes" . Visit their website.

When writing your protocol it is important to consider who else
needs to be consulted during this process; colleagues, support
departments, statisticians etc. For further information,
please see the Standard Operating
Procedures page.

To view examples of ethically approved UH Bristol sponsored
trials please use the links in the table below:

The NIHR Health Technology Assessment (HTA) programme publishes
the protocols of all the trials they fund on their website. Each
trial has its own project page which includes a link to the
protocol: please click here

Further guidance for researchers wishing to develop a protocol
for a clinical trial can be found in the SPIRIT statement. SPIRIT
(Standard Protocol Items: Recommendations for Interventional
Trials) is an international initiative that aims to improve the
quality of clinical trial protocols by defining an evidence-based
set of items to address in a protocol. Further information can be
found here: http://www.spirit-statement.org/

If you would like UH Bristol to act as Sponsor for your proposed
research project please also ensure the required standard wording
is included in your protocol. Please see our 'Writing a protocol to GCP' SOP